Informed Consent: Competent Persons

Case Study: Reibl vs. Hughes

Reibl, 44, had surgery to remove an occlusion in an artery. The reason for
the surgery was future risk of stroke, and concern about current headaches and
hypertension. The surgery was well performed by Hughes, but the patient had
a stroke and became paralyzed. He sued on the grounds that he had not been sufficiently
informed of the risk of surgery: of 60-70 such operations performed by the doctor,
8-10 had died. The patient needed another 1.5 years of work to qualify for a
pension, and said he would not have had the operation if he had known how risky it
is. An Ontario court ruled in favor of the plaintiff, but was overturned by
the Ontario Supreme Court, but supported by the Supreme Court of Canada.

Question: Was Hughes liable? Unethical?

Standards of Informed Consent

The issue: What should doctors do to insure that when patients consent to a
procedure they are adequately informed?

Standard 1 (UK): A physician needs to disclose what another physician in a
similar situation would disclose.

Standard 2 (US): A physician needs to disclose what an ordinary reasonable person
would want to know.

Standard 3 (CDN): A physician needs to disclose what an objective reasonable
person in the patient's particular position would want to know.

Tests of Informed Consent

Subjective: Would the patient have had the operation?

Objective: Would the patient have had the operation if reasonable?

Relevant Rights and Duties

Doctors have a duty to protect health.

People have a right to have health protected by physicians.

Doctors have a duty to disclose risks.

People have a right to determine what is done with their bodies.

Information and Comprehension

Standard of comprehension: information must be pitched at a level that the
patient can understand.

Comprehension problems:

Medical information may be technical and statistical.

Patient may be uneducated or stressed.

Patient may have language difficulties.

Cultural Questions

Should a patient or the patient's family be responsible for medical decisions?

Should the concept of autonomy be broadened to include family units?

Informed Consent: Incompetent Persons

Cases

1. Stephen (S.D.). 7 year old boy, severely retarded, blind, no communication,
no abilities, in pain. Needs a shunt to survive. Parents deny permission to
put in the shunt, but the courts rule that he should get it.

2. Eve. 24 year old moderately retarded woman with aphasia. Her mother wanted
to have her sterilized, but the Supreme Court of Canada rejected sterilization.

3. Samantha. 11-year old girl with advancing bone cancer. She does not want
more treatment, but her parents do. Eventually, the parents decide to discontinue
chemotherapy.

4. Tattoos and piercings.

5. Blood transfusions for Jehovah Witnesses.

Principles: Which are acceptable?

1. The patient should always decide.

2. The parent or legal guardian should always decide.

3. Courts may make decisions based on the best interests of the patient.

4. Physicians may decide based on what an ordinary reasonable person
would decide under similar circumstances.

5. Proxy decision makers should try to put themselves into the situation of
the patient and then decide from that perspective.

Rights of Incompetent Persons?

1. None?

2. Same rights as other persons?

3. Limited sets of rights?

Review Questions for Week 5

What are the different standards of medical disclosure?

What are the rights and duties of patients and doctors with respect to informed
consent?

Essay question: What standards of medical disclosure are most consistent
with patients' rights and consequences? For each option, discuss: consequences pro, con, and overall; rights pro, con, and overall; your overall conclusion concerning the options based on consequences and rights.

Should the cultural background of patients be taken into account in considering
their autonomy to make medical decisions for themselves?

According to Kluge, what are the rights of incompetent patients?

What principles have the courts tried to apply to cases of incompetent patients?

Essay question: What principles should be used to make decisions for incompetent
patients? Discuss the relevance of beneficence, non-malfeasance, autonomy, and equality.